A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight

Part of paid clinical trials in Conyers, Georgia.

Sponsor
Novo Nordisk A/S
Study ID
NCT07745504
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cagrilintide — DRUG
    Cagrilintide will be administered subcutaneously.
  • Placebo cagrilintide — DRUG
    Placebo matched to cagrilintide will be administered subcutaneously.
  • Placebo semaglutide — DRUG
    Placebo matched to semaglutide will be administered subcutaneously.

Study Details

The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. Which treatment participants get is decided by chance. Cagrilintide is a new medicine under development that doctors cannot prescribe yet, but it has been tested in humans before. Participants will be in this clinical study for about 9 months.

Key Dates

First listed
Aug 4, 2026
Start date
Aug 4, 2026
Status verified
Jul 2026
Primary completion
May 18, 2027
Completion
Jul 6, 2027

Study Design

Enrollment
285 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2
    Participants will receive cagrilintide along with placebo matched to semaglutide in device 1 and placebo matched to cagrilintide in device 2 subcutaneously (s.c) once weekly for 26 weeks.
  • Experimental: Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1
    Participants will receive cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks.
  • Placebo Comparator: Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1
    Participants will receive placebo matched to cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks.

Primary Outcome Measure

Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 26) ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Hope Clin Res & WellnessConyersGeorgia30094-
East West Med Res InstHonoluluHawaii96814-
Walgreens - Store 11760Oak ParkIllinois60302-
Midwest Inst For Clin ResIndianapolisIndiana46260-
The Alliance for Multispecialty Research LLC AMRLexingtonKentucky40509-
PharmQuestGreensboroNorth Carolina27408-
KDCILM, LLC & Accellacare US, Inc.WilmingtonNorth Carolina28401-
Coastal Carolina Res CtrNorth CharlestonSouth Carolina29405-
Health Res of Hampton RoadsNewport NewsVirginia23606-
National Clin Res Inc.RichmondVirginia23294-
Selma Medical AssociatesWinchesterVirginia22601-3834-

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Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Hope Clin Res & Wellness· Conyers, GAEast West Med Res Inst· Honolulu, HIWalgreens - Store 11760· Oak Park, ILMidwest Inst For Clin Res· Indianapolis, INThe Alliance for Multispecialty Research LLC AMR· Lexington, KYPharmQuest· Greensboro, NC

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